pdufa.bio
HomeDecisions › GRCE 2026-04-23

GRCE FDA decision — Apr 23, 2026

✕ COMPLETE RESPONSE LETTER

Grace Therapeutics Inc. — GTX-104 - (STRIVE-ON) · Subarachnoid hemorrhage (SAH).

Run-up into the decision (T-120 → T+5)

PDUFA 4/23/26$5.13$2.9911/6/25
Daily close, T-120 (11/6/25) through T+5. Run-up high $5.13 on 4/3/26, low $2.99 on 11/17/25 (T-120 to T-1). FDA decision 4/23/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-23
OutcomeCRL
Drug / candidateGTX-104 - (STRIVE-ON)
CompanyGrace Therapeutics Inc.
120-day run-up (T-120→T-1)+37.7%